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Anti-bacterial

Antibiotics for C. Difficile (OpTION Trial)

Phase 4

Recruiting

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed current diagnosis of CDI, determined by having >3 loose or semi-formed stools for participants over 24 hours AND Positive stool assay for C. difficile EIA positive for toxin A/B; or Cytotoxin assay; or Nucleic Acid Amplification Test (NAAT, PCR or LAMP) based detection of toxigenic C. difficile

>3 loose or semi-formed stools for participants over 24 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90 since randomization

Awards & highlights

OpTION Trial Summary

This trial will compare two different treatments for recurrent Clostridium difficile infection, to see which is more effective.

Who is the study for?

Adults over 18 with a confirmed first or second recurrence of C. difficile infection within the past 3 months, who have had more than three loose stools in 24 hours and can provide informed consent. Pregnant or nursing women are excluded, as well as those allergic to vancomycin or fidaxomicin, on long-term antibiotics, with severe CDI symptoms like hypotension or ileus, other causes of chronic diarrhea, prior extensive treatment for CDI, active COVID-19 (unless recovered), and inability to take oral medication.Check my eligibility

What is being tested?

This study is testing if treating recurrent C. difficile infections with either fidaxomicin alone or vancomycin followed by a tapering dose of vancomycin is more effective than just standard vancomycin treatment. Participants will be randomly assigned to one of these treatments to compare outcomes.See study design

What are the potential side effects?

Potential side effects from the medications may include nausea, vomiting, abdominal pain and discomfort. Vancomycin might also cause kidney issues in rare cases while fidaxomicin could lead to allergic reactions.

OpTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with CDI, with symptoms and positive stool test results.

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I have had more than 3 loose stools in the last 24 hours.

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I am older than 18 years.

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I am not pregnant or breastfeeding.

OpTION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 90 since randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 90 since randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 since randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine symptom resolution during treatment without any of the following: diarrhea recurrence; other non-fatal clinical events including severe abdominal pain, toxic megacolon, and colectomy; and death.

Secondary outcome measures

C.diff Health Related Quality of Life (HRQOL)

CDI Composite outcome measure

Diarrhea Composite outcome measure

+4 more

OpTION Trial Design

3Treatment groups

Experimental Treatment

Group I: Vancomycin T/PExperimental Treatment1 Intervention

Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile

Group II: VancomycinExperimental Treatment1 Intervention

Standard 10-day vancomycin treatment for Clostridium difficile

Group III: FidaxomicinExperimental Treatment1 Intervention

Standard 10-day fidaxomicin treatment for Clostridium difficile

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

2005

Completed Phase 4

~7930

Fidaxomicin

2016

Completed Phase 4

~1630

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,304,735 Total Patients Enrolled

Stuart B. Johnson, MD BAStudy ChairEdward Hines Jr. VA Hospital, Hines, IL

Dale N Gerding, MDStudy ChairEdward Hines Jr. VA Hospital, Hines, IL

Media Library

Fidaxomicin (Anti-bacterial) Clinical Trial Eligibility Overview. Trial Name: NCT02667418 — Phase 4

Clostridium Research Study Groups: Fidaxomicin, Vancomycin, Vancomycin T/P

Clostridium Clinical Trial 2023: Fidaxomicin Highlights & Side Effects. Trial Name: NCT02667418 — Phase 4

Fidaxomicin (Anti-bacterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02667418 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you outline any other relevant research related to this treatment?

"The initial findings of this treatment were reported in Sacramento Pediatric Gastroenterology a decade ago. To date, the number of completed studies exceeds 160, with 55 trials actively recruiting patients; notably many are taking place at Ann Arbor's medical facilities."

Answered by AI

What medical conditions is this remedy usually administered to treat?

"This medication is often prescribed to treat staphylococcal infections, as well as conditions like enterocolitis induced by Staphylococcus aureus and cases where the patient's body weight is at least 12.5kg."

Answered by AI

Is this experiment accepting participants currently?

"Affirmative. According to the data provided on clinicaltrials.gov, this trial has been open since December 21st 2015 and is actively recruiting for 549 participants based in 23 different sites."

Answered by AI

To what extent are hospitals participating in this experimental program?

"This experiment is recruiting participants at VA Ann Arbor Healthcare System, located in the city of Ann Arbor, Michigan; Durham VA Medical Center in North carolina’s capital, Durham and Atlanta VA Medical & Rehabilitation Centre situated in Decatur Georgia. Furthermore, 20 other sites across the US are also hosting this trial."

Answered by AI

Has this remedy been green-lighted by the Food & Drug Administration?

"On our assessment scale, this therapy was awarded a score of 3 as it has been granted approval for use in the 4th phase of clinical trials."

Answered by AI

To what extent is this clinical trial being participated in?

"Indeed, online records at clinicaltrials.gov confirm that this investigation is actively recruiting participants, with an initial post date of December 21st 2015 and a recent edit on January 4th 2022. In total, 549 individuals are needed for the trial across 23 separate sites."

Answered by AI